FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
FUBUKI XF Neurovascular Long Sheath
K Number: K213589
·
Decision Mar 24, 2022
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
84
Review Days
132
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Basic Information
- Device Name
- FUBUKI XF Neurovascular Long Sheath
- K Number
- K213589
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Asahi Intecc Co., Ltd.
- Date Received
- November 12, 2021
- Decision Date
- March 24, 2022
- Product Code
- QJP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
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